Comparing the effectiveness of an educational intervention based on the determinant of effective and ineffective PRECEDE-PROCEED model on improving self-care quality, glucose control and lifestyle modification of Pre-diabetic persons
A study to develop and evaluate the effectiveness of a lifestyle modification program in pre-diabetic individuals in Hoveyzeh: a PRECED- PROCEED guided program
Design
A randomized, double-blind, controlled, Two-center trial conducted from, 2019 through 2020
Settings and conduct
Pre- and post a randomized controlled trial that is allocating groups selected from two different geographical areas to reduce the chance of sharing information. The reassessments will be conducted after 3 months of intervention. The educational content used in this study is in accordance with the International Federation of Diabetes (IDF) guidelines.
Participants/Inclusion and exclusion criteria
Pre-diabetic people - aged 30-75 years - resident in Hoveyzeh
Intervention groups
Educational intervention group: A program for lifestyle modification based on the most effective PRECEDE-PROCEDURE model constructs: Advice on diet changes, exercise to achieve and maintain ideal body weight, stress management techniques, regularly from training sessions, email and social networks and SMS will receive.
Control group: A program for lifestyle modification based on the most ineffective PRECEDE-PROCEDURE model constructs: Advice on diet changes, exercise to achieve and maintain ideal body weight, stress management techniques, regularly from training sessions, email and social networks and SMS will receive.
Main outcome variables
Quality of life, HbA1c hemoglobin concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171226038083N1
Registration date:2019-11-11, 1398/08/20
Registration timing:retrospective
Last update:2019-11-11, 1398/08/20
Update count:0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Majed Meripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 5096
Email address
majed8112@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-18, 1397/10/28
Expected recruitment end date
2019-07-19, 1398/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of an educational intervention based on the determinant of effective and ineffective PRECEDE-PROCEED model on improving self-care quality, glucose control and lifestyle modification of Pre-diabetic persons
Public title
lifestyle modification program in pre-diabetic individuals
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pre-diabetic people
Age of 30 to 75 years
Resident of Hovizeh
Exclusion criteria:
Acute or chronic comorbidities such as mental illness, mental retardation, chronic infectious disease (tb), or motor disability
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
242
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization: From 2000 patients with pre-diabetes identified in Hoveyzeh health centers, 242 individuals were selected by Winpepi software. Then, the subjects were randomly divided into intervention and control groups by simple randomization method. The number of intervention and control groups was equal to 121 persons.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blv.
City
Ahvaz
Province
Khouzestan
Postal code
61537-15794
Approval date
2018-12-21, 1397/09/30
Ethics committee reference number
IR.AJUMS.REC.1397.689
Health conditions studied
1
Description of health condition studied
per-diabetic people
ICD-10 code
R73.03
ICD-10 code description
Prediabetes
Primary outcomes
1
Description
Hemoglobin A1c (HbA1c)
Timepoint
Starting the study and 3 months later
Method of measurement
we use CERA-STAT 2000 Analyzer (CERAGEM MEDISYS inc)
2
Description
Health-related quality of life (HR-Qol)
Timepoint
At the base-line and the end of study (0 and 6-month)
Method of measurement
Assessing the Quality of Life of the Diabetic patients by using the World Health Organization (WHO) Quality of Life Questionnaire:. Effect of Intervention
Secondary outcomes
1
Description
The patient's readiness to change in each of the three areas of the diet, physical activity and stress
Timepoint
Before intervention and after intervention
Method of measurement
A researcher-made questionnaire based on the PRECEDE PROCESS model that will be standardized in the study process
Intervention groups
1
Description
Based on the needs assessment performed in the previous phase of the study, a lifestyle modification program included: counseling on diet changes, exercise to achieve and maintain ideal body weight, stress management techniques, etc. regularly from training sessions, email and Social networks and SMS will receive. To formulate the content, the World Diabetes Federation Reference Book will be used. This manual is uses for distance education of the HOPE project to obtain PG Certificate in diabetes education.The intervention group received 4 sessions of 60 minutes on one month for the intervention group. The educational content of these 4 sessions consisted of topic importance and problem expression, diet, physical activity and exercise, and stress management. Three months after the end of the training sessions, the intervention group was re-evaluated.
Category
Lifestyle
2
Description
Control group: Only once at the beginning of a regular consultation will receive care according to the country's instructions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hoveyzeh Lab
Full name of responsible person
Rasol Khajeh
Street address
Imam Reza Medical Center., Imam Reza Blvd., Koot District ., Hoveyzeh Town
City
Hoveyzeh
Province
Khouzestan
Postal code
6445143367
Phone
+98 61 3678 2004
Email
Majed8112@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Badvi
Street address
Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
+98 61 3336 1544
Email
Research@ajums.ac.ir
Grant name
Social Determinants of Health Research Center, Ahvaz Jundishapur University of Medical Sceinces
Grant code / Reference number
-SDH-9719
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Meripour Majed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No37, 11 Ave., Imam Reza Blvd., Kianshahr District., Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6445143367
Phone
+98 61 3333 3024
Email
Majed8112@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Khafaie Morteza
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Ahvaz Jundishapur University of Medical Sciences., Esfand Ave ., Farvardin Blvd., Golestan Hwy., Ahvaz Town
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
No more information
When the data will become available and for how long
Does not have
To whom data/document is available
Any natural or legal person requesting access to information can be reviewed if the project researcher is identified as having used the information for research purposes.
Under which criteria data/document could be used
Analyzing and reviewing the effectiveness of the study
From where data/document is obtainable
Public health and health education and promotion Departments, Health Faculty, Ahvaz Jundishapur University of Medical Sciences, Esfand Ave, Farvardin Blvd, Golestan Hwy, Ahwaz Town
Contact number: 0098 61 33738315 - 0098 61 33738282 -0098 61 33738269
Internal: 2874
Mobile: 0098 913371679 and 0098 9166555978
Mohamadian Hashem , Khafaie Morteza : Supervisors
What processes are involved for a request to access data/document